Model Number N/A |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Information (3190)
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Event Date 04/19/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical product: unk oxford femoral component, catalog #: unk, lot #: unk, medical product: unk oxford bearing, catalog #: unk, lot #: unk.Foreign source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.
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Event Description
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It was reported that a patient underwent an initial right knee replacement procedure.Subsequently, at the 6 month check, tibia loosening was observed, no revision surgery has been reported to date.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical product: oxf anat brg rt x-sm 3mm pma catalog #: 160790 lot #: 3936847, medical product: oxf ph3 cementless fem sz xsm catalog #: 154912 lot #: 3945373.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It was reported that a patient underwent an initial right knee replacement procedure.Subsequently, at the 6 month check, tibia loosening was observed, no revision surgery has been reported to date.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.X-ray review: overall, the implants appear appropriately sized and positioned.However, the tibial tray appears slightly short of the tibial plateau medially in the ap x-rays.The oxford partial knee surgical technique states that the tibial tray should be flush with (or have less than 2 mm overhang from) the medial edge of the tibial plateau.The cement mantle does appear to be uneven and a larger amount of cement is visible underneath the lateral side of the tibial tray in all ap x-rays.Radiolucent marks are visible around the cement mantle of the tibial tray in the ap x-rays.It is not possible to confirm the loosening of the tibial component from the information provided, and it is stated in the complaint description that ''no revision surgery is planned yet (patient has no pain)'' at the 6-month visit.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It was reported that a patient underwent an initial right knee replacement procedure.Subsequently, at the 6 month check, tibia loosening was observed, no revision surgery has been reported to date.
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Search Alerts/Recalls
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